Last synced on 30 September 2022 at 11:05 pm

iBreastExam

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190575
510(k) Type
Abbreviated
Applicant
UE LifeSciences Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/16/2019
Days to Decision
132 days
Submission Type
Summary

iBreastExam

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190575
510(k) Type
Abbreviated
Applicant
UE LifeSciences Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/16/2019
Days to Decision
132 days
Submission Type
Summary